The present invention is concerned with an improved diagnostic agent for the rapid and sensitive detection of total bilirubin in body fluids, particularly in urine.
The detection of bilirubin is of great importance in the diagnosis of disease of the liver and gall bladder. Bilirubin, a highly pigmented yellow compound, is a degradation product of hemoglobin. The appearance of direct and indirect (total) bilirubin in the urine can provide an early indication of liver disease and is often detected long before the development of jaundice. Bilirubin provides early detection of hepatitis, cirrhosis, gallbladder disease, and cancer, and should be included in every routine urinalysis. 1 FNT 1. Strasinger, S. K.: Urinalysis and Body Fluids. F. A. Davis, Philadelphia, 1994.
Methods for the detection of bilirubin in the urine have been known for a long time. Historically, methods are dependent upon the evaluation of the colored compounds formed by the coupling of bilirubin with diazonium salts. For this purpose, diazosulfanilic acid, 2,4-dichloroaniline diazonium salt, 2,6-dichlorobenzene-diazonium-tetrafluoroborate, and p-nitrobenzene-diazonium-p-toulenesulfonate in an acid medium have previously been most used.